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Expanding Patient Access to Investigational New Drugs: Overview of Intermediate and Widespread Treatment Investigational New Drugs, and Emergency Authorization in Public Health Emergencies
Individual patients with life-threatening or severely debilitating diseases can petition the U.S. Food and Drug Administration (FDA) through their physicians to have expanded access (EA) to drugs that are in clinical trials but have not reached full FDA approval (the “single-patient” investigational...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Elsevier
2018
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6058931/ https://www.ncbi.nlm.nih.gov/pubmed/30062226 http://dx.doi.org/10.1016/j.jacbts.2018.02.001 |